Sleep ApneaPhase 4NCT00424658
Sleep Apnea. Concordance Between Non-reference and Reference Centres
A Phase 4 study testing SAHS diagnosis in people with Sleep Apnea, run by Hospital Clinic of Barcelona at 2 sites in Spain.
Trial summary
When a disorder is as prevalent as sleep apnea hypopnea syndrome various medical levels and strategies should be implicated. We to evaluate the degree of concordance in management between a sleep reference centre and non-reference centres. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- SAHS diagnosis
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2000to Apr 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Supected sleep apnea
Who cannot join
- Major diseases
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Clinic. Fundacio Clinic.IDIBAPS
Barcelona, 08036
Hospital Clinic.Fundacio Clinic.IDIBAPS
Barcelona, 08036
About this study
When a disorder is as prevalent as sleep apnea hypopnea syndrome various medical levels and strategies should be implicated. We to evaluate the degree of concordance in management between a sleep reference centre and non-reference centres.
Read the detailed description
INTRODUCTION: When a disorder is as prevalent as SAHS, different medical levels should be involved to facilitate diagnosis for all patients, or at least those that are in moderate-severe or risk groups. A good option could be to transfer the patient assessment to non-reference centres (NRC). Therefore, the aim of the present study was to evaluate this strategy by analysing the degree of concordance between RC and NRC in treatment decision and management of SAHS patients.
MATERIALS AND METHODS: Study subjects: The study population consisted of 88 consecutive subjects with a suspicion of SAHS (age 50±11 years, 81 % male, BMI 30±4 K/m2) from the out-patient clinics of three NRC in the Barcelona area: Hospital Asil de Granollers, Hospital General de Vic and Hospital de Terrassa.
Study design: The patients were evaluated independently, at random, over the course of 1 month in the RC and NRC. In both types of centre, the patient evaluation was carried out on the basis of the clinical history, with a specific questionnaire about sleep disordered breathing, and a sleep study in the hospital. The evaluation was performed by a sleep physician in the RC and by a respiratory physician with training in sleep medicine in the NRC. In both cases, the choice of treatment was registered on an ordinal scale with four points: 1= No diagnosis of SAHS and patient is discharged; 2= Mild SAHS, patient should follow a conservative treatment and clinical control; 3= Moderate to severe SAHS, patient should begin continuous positive air pressure (CPAP) treatment; 4= Other sleep disorders are diagnosed (RC), or there is a need for full-night PSG owing to a discordance between clinical features and respiratory polygraphy in NRC. The indication for CPAP treatment followed the national-SEPAR guidelines summarized as: 1) Patients with severe SAHS-related symptoms with an AHI>10; or 2) Patients with mild to moderate clinical symptoms with an AHI>30. The human ethics committee of our hospital approved the protocol and informed consent was obtained from all the patients. Sleep studies: Reference hospital: Full-night polysomnography was performed in the usual manner. Briefly, the variables registered were electroencephalogram, chin electromyogram, electro-oculogram, tibial electromyogram, arterial oxygen saturation, ribcage and abdominal motion and their sum. Airflow was measured by cannula/thermistor. An apnea was defined as the absence or airflow equal to or greater than 10 seconds. Hypopnoea was defined by any discernible reduction in the amplitude of the airflow signal ending in an arousal and/or association with a 3% desaturation, with a duration of at least 10 seconds. An expert technician scored sleep stages and respiratory variables manually. An apnea-hypopnoea index (AHI) equal to or greater than 10 was considered abnormal.Non-reference centres: patients received a respiratory poligraphy with recording of body position, ribcage and abdominal motion, snoring, arterial oxygen saturation and airflow using a cannula/thermistor. The respiratory physician performed a manual scoring of the recording. The definitions of hypopnoea and apnea resembled those mentioned above, except in the case of arousal. Data analysis: Data were entered using SPSS 10.0 and imported to STATA 7.0 to perform the analysis (StatatCorp. 1999. Stata Statistical software: Release 7.0. College Station, TX: Stata Corporation). Descriptive analysis: Data were expressed as mean ± SD or percentage for quantitative and qualitative variables, respectively. For continuum variables, a logarithmic transformation was undertaken to normalise the distribution, if necessary. If the distribution was not symmetrical, data were expressed as percentiles. Concordance analysis: Evaluation of the concordance of the final outcome and the choice of treatment, between the RF and the NFC centres, was performed by using the statistic Kappa balanced, penalizing extreme discrepancies, following the classification of Landis \& Koch (25). This procedure was also used for the concordance in the result of the AHI of the sleep study, categorised as follows: <10, 10-29, ≥30. Concordance in the results of the sleep study (AHI and CT90) was evaluated in accordance with the Band \& Altman methodology and the concordance coefficient of Lin.
- Conditions
- Sleep Apnea
- Being tested
- SAHS diagnosis
- Keywords
- breathing disorders
- Medical subject headings
- Sleep Apnea Syndromes, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAHS diagnosisProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance in sleep apnea management between reference vs non reference centres
Secondary outcomes (1)
Concordane betwen polysomnographic data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2007 (estimated)
- Study startJan 2000
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Investigators
- Josep Montserrat, MD, Study director, Fundacio Clinic. IDIBAPS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424658
- Sponsor's protocol ID
- Sleep concordance
- Status last verified
- Jan 2007
- First submitted
- 17 Jan 2007
- Last updated
- 1 Apr 2015
- Results posted
- No
Publications
Hernandez L, Torrella M, Roger N, Llunell A, Ballester E, Quinto L, Serrano M, Masa F, Montserrat JM. Management of sleep apnea: concordance between nonreference and reference centers. Chest. 2007 Dec;132(6):1853-7. doi: 10.1378/chest.07-0250. Epub 2007 Oct 9.
PubMed 17925431
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea. Concordance Between Non-reference and Reference Centres
- ClinicalTrials.gov ID
- NCT00424658
- Acronym / sponsor ID
- Sleep concordance
- Conditions
- Sleep Apnea
- Keywords
- breathing disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Jan 2000
- Study completion
- Apr 2004
- First posted
- 19 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When a disorder is as prevalent as sleep apnea hypopnea syndrome various medical levels and strategies should be implicated. We to evaluate the degree of concordance in management between a sleep reference centre and non-reference centres.
Detailed description
INTRODUCTION: When a disorder is as prevalent as SAHS, different medical levels should be involved to facilitate diagnosis for all patients, or at least those that are in moderate-severe or risk groups. A good option could be to transfer the patient assessment to non-reference centres (NRC). Therefore, the aim of the present study was to evaluate this strategy by analysing the degree of concordance between RC and NRC in treatment decision and management of SAHS patients.
MATERIALS AND METHODS: Study subjects: The study population consisted of 88 consecutive subjects with a suspicion of SAHS (age 50±11 years, 81 % male, BMI 30±4 K/m2) from the out-patient clinics of three NRC in the Barcelona area: Hospital Asil de Granollers, Hospital General de Vic and Hospital de Terrassa.
Study design: The patients were evaluated independently, at random, over the course of 1 month in the RC and NRC. In both types of centre, the patient evaluation was carried out on the basis of the clinical history, with a specific questionnaire about sleep disordered breathing, and a sleep study in the hospital. The evaluation was performed by a sleep physician in the RC and by a respiratory physician with training in sleep medicine in the NRC. In both cases, the choice of treatment was registered on an ordinal scale with four points: 1= No diagnosis of SAHS and patient is discharged; 2= Mild SAHS, patient should follow a conservative treatment and clinical control; 3= Moderate to severe SAHS, patient should begin continuous positive air pressure (CPAP) treatment; 4= Other sleep disorders are diagnosed (RC), or there is a need for full-night PSG owing to a discordance between clinical features and respiratory polygraphy in NRC. The indication for CPAP treatment followed the national-SEPAR guidelines summarized as: 1) Patients with severe SAHS-related symptoms with an AHI>10; or 2) Patients with mild to moderate clinical symptoms with an AHI>30. The human ethics committee of our hospital approved the protocol and informed consent was obtained from all the patients. Sleep studies: Reference hospital: Full-night polysomnography was performed in the usual manner. Briefly, the variables registered were electroencephalogram, chin electromyogram, electro-oculogram, tibial electromyogram, arterial oxygen saturation, ribcage and abdominal motion and their sum. Airflow was measured by cannula/thermistor. An apnea was defined as the absence or airflow equal to or greater than 10 seconds. Hypopnoea was defined by any discernible reduction in the amplitude of the airflow signal ending in an arousal and/or association with a 3% desaturation, with a duration of at least 10 seconds. An expert technician scored sleep stages and respiratory variables manually. An apnea-hypopnoea index (AHI) equal to or greater than 10 was considered abnormal.Non-reference centres: patients received a respiratory poligraphy with recording of body position, ribcage and abdominal motion, snoring, arterial oxygen saturation and airflow using a cannula/thermistor. The respiratory physician performed a manual scoring of the recording. The definitions of hypopnoea and apnea resembled those mentioned above, except in the case of arousal. Data analysis: Data were entered using SPSS 10.0 and imported to STATA 7.0 to perform the analysis (StatatCorp. 1999. Stata Statistical software: Release 7.0. College Station, TX: Stata Corporation). Descriptive analysis: Data were expressed as mean ± SD or percentage for quantitative and qualitative variables, respectively. For continuum variables, a logarithmic transformation was undertaken to normalise the distribution, if necessary. If the distribution was not symmetrical, data were expressed as percentiles. Concordance analysis: Evaluation of the concordance of the final outcome and the choice of treatment, between the RF and the NFC centres, was performed by using the statistic Kappa balanced, penalizing extreme discrepancies, following the classification of Landis \& Koch (25). This procedure was also used for the concordance in the result of the AHI of the sleep study, categorised as follows: <10, 10-29, ≥30. Concordance in the results of the sleep study (AHI and CT90) was evaluated in accordance with the Band \& Altman methodology and the concordance coefficient of Lin.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Supected sleep apnea
Key exclusion criteria (1 listed)
- Major diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAHS diagnosis | Procedure or surgery | – |
Primary outcome
Concordance in sleep apnea management between reference vs non reference centres
1 secondary outcome
Concordane betwen polysomnographic data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Derived from this study: PubMed 17925431Hernandez L, Torrella M, Roger N, Llunell A, Ballester E, Quinto L, Serrano M, Masa F, Montserrat JM. Management of sleep apnea: concordance between nonreference and reference centers. Chest. 2007 Dec;132(6):1853-7. doi: 10.1378/chest.07-0250. Epub 2007 Oct 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep Montserrat, MD study director
Fundacio Clinic. IDIBAPS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SAHS diagnosis in people with Sleep Apnea, run by Hospital Clinic of Barcelona at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance in sleep apnea management between reference vs non reference centres. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00424658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.